Proactive Outreach With FIT (PROOF)

A Randomized, Multi-site Trial to Boost Colorectal Cancer Screening Rates Through Proactive Outreach and Navigation in Federally Qualified Health Centers in Brooklyn

The purpose of the study is to boost colorectal cancer (CRC) screening rates in an underserved population in Brooklyn through organized, proactive outreach of mailed Fecal Immunochemical Tests (FIT), utilizing evidence-based interventions tailored to the needs of the population.

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Proactive Screening Outreach

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11203
      • NYU Langone Health
    • Brooklyn, New York, United States, 11206
      • Community Health Care Network of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Patients

• Men and women aged 45-75
• Receiving medical care at NYULH Flatbush FHC and CHN Crown Heights, East New York, East New York Health Hub, Williamsburg clinic sites.
• Due or overdue for CRC screening.
• Medical visit of any type at clinic in past year.

Providers

• Physicians or primary care givers at Flatbush FHC or CHN Crown Heights, East New York, East New York Health Hub, Williamsburg clinic sites (CHN employees)
• Provide care to CRC screen-eligible patients

Exclusion Criteria:

• Age younger than 45 years old or greater than 75 years old
• Up-to-date with colorectal cancer screening:
• History of colorectal cancer, inflammatory bowel disease, colorectal polyps, or total colectomy
• In hospice care
• Patients 66 years or older living long-term in an institution or with advanced illness
• No address or phone number on file

Providers

• No longer employed at an included clinic site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proactive Screening Outreach; Participants assigned to the interventional arm will receive proactive outreach of mailed Fecal Immunochemical Tests (FIT) to screen for colorectal cancer.	Behavioral: Proactive Screening Outreach; Individuals in the interventional arm will receive an information letter, followed by mailed FIT kit. Individuals that do not respond will receive reminder phone calls. Individuals that do respond will receive navigation to assist with completion of FIT and the colonoscopy if FIT is abnormal. Clinic processes will be closely followed and the primary care provider will be informed of the program.
No Intervention: Standard of Care; Participants assigned to the standard of care group will receive usual care (i.e., opportunistic screening for colorectal cancer).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of Participants who Complete FIT Test by Month 6	Up to Month 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of Participants with Positive FIT who Complete Colonoscopy by Month 6	Up to Month 6

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Aasma Shaukat, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 23-01032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Aasma.Shaukat@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Aasma.Shaukat@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No